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Completed

NCT Number: NCT02589041

US-guided Sciatic Nerve Block: Evaluation of the Intraneural Ropivacaine Minimal Effective Volume (MEV90)

This prospective, double-blinded study evaluates intraneural ropivacaine 1% Minimal Effective Volume (MEV90) for ultrasound-guided (US) popliteal sciatic nerve block, with Up-and-down methodology.

To evaluate any neurological complications, an electrophysiological assessment will also be performed preoperatively and at 5 weeks after surgery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Ortopedico G. Pini

Milan, Milano, 20122, Italy

About this study

At least 45 patients undergoing hallux valgus repair will be enrolled. A baseline bilateral sciatic nerve electrophysiological study will be performed preoperatively.

Patients will be placed in prone position and a high-frequency (8-12 MHz) linear array transducer (Snerve, Sonosite, USA) will be used to identify the sciatic nerve in a transverse cross-sectional view at the apex of the popliteal fossa. As the best view of the sciatic nerve with its paraneural and neural sheath, just proximal to the point of bifurcation, will be obtained, the nerve dimension (medial-lateral and cranio-caudal diameters) will be determined and registered.

An 80 mm 22-gauge needle (Sonoplex, Pajunk, Germany) will be inserted using the US-guided in-plane technique under the epineurium. The positioning will be evaluated injecting 1 ml of sodium-chloride 0.9% solution and observing the nerve swelling, if correct the local anaesthetic (LA) solution will be injected.

The first patient will receive 15 ml of ropivacaine 1% (150 mg). Following patients will receive LA volume based on Up-and-down methodology.

Clinical follow-up will be performed at 12, 24, 48 hours, 1 and 5 weeks and 6 months after surgery.

At 5 weeks electrophysiological study will also be performed in all patients and repeated at 6 months in case of positive findings.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 18 years old
  • ASA I-III
  • Signed informed consensus

Exclusion criteria

  • ASA IV
  • Unstable neurological disease
  • DM type I-II
  • Allergy to ropivacaine-mepivacaine
  • Opioid chronic treatment
  • Consensus refusal or not valid
  • Rheumatoid arthritis
  • Baseline electrophysiological study positive finding
  • Postoperative intensive care required

Treatment and study plan

intraneural sciatic nerve injection

Procedure

A popliteal intraneural sciatic nerve block will be performed under ultrasound guidance. Minimal effective volume will be evaluated performing a randomization based on the Up-and-down methodology.

A baseline and postoperative electrophysiological study will assess the presence of any neurological complication.

Ropivacaine 1%

Drug

Primary outcomes

  1. Evaluation of the Intraneural Ropivacaine Minimal Effective Volume in 90% of patients (MEV90)

    Time frame: 6 months

Secondary outcomes

  1. electrophysiological assessment of neurological deficit

    Time frame: 5 weeks

    Electromyography of sciatic nerve bilaterally. Evaluation of velocity (m/Sec), amplitude (mV) and latency (mSec) of both peroneal and tibial components

Sponsors and collaborators

Lead sponsor

ASST Gaetano Pini-CTO

Other

Registry information

Official study title

Ultrasound-guided Popliteal Sciatic Nerve Block: an Evaluation of the Intraneural

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Oct 28, 2015
Registry last updated
Aug 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.